Unique Therapy for Advanced Heart Failure Granted Fast Track Status

Ixmyelocel-T reduces death risk and cardiovascular hospitalization

The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational multicellular therapy, ixmyelocel‑T (Vericel), for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM).

Ixmyelocel‑T was evaluated in the ixCELL-DCM study, a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial designed to assess its efficacy, safety and tolerability vs. placebo in patients with end-stage heart failure due to ischemic DCM.

All patients were on maximized heart failure drug therapy, had an automatic implantable cardiac defibrillator or cardiac resynchronization therapy, and were unlikely to benefit from either surgical or percutaneous interventional revascularization procedures. The study met its primary endpoint, with a 37% reduction in the composite endpoint, primarily driven by a reduction in all-cause deaths and cardiovascular hospitalizations.

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Ixmyelocel-T is an investigational autologous expanded multicellular therapy administered via transendocardial catheter-based injections. It is developed utilizing Vericel's proprietary cell-processing system to selectively expand the population of mesenchymal stromal cells and activated macrophages from the patient's own bone marrow.